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Evaluation of curative effect of traditional Chinese medicine on chronic kidney disease and dialysis patients with severe new coronavirus infection: A multicenter, prospective, open label, blank control, blind evaluation and randomized controlled trial.

Evaluation of curative effect of traditional Chinese medicine on chronic kidney disease and dialysis patients with severe new coronavirus infection based on "lung-intestine-kidney" axis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071494
Enrollment
Unknown
Registered
2023-05-16
Start date
2023-05-17
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 diseases

Interventions

test team:Basic western medicine treatment+traditional Chinese medicine intervention treatment(Huashi Paidu Yishen recipe/Hushen Jiedu recipe)

Sponsors

Ningbo Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of western medicine conforms to novel coronavirus's criteria for diagnosis and severe typing of infection, CKD's criteria for diagnosis and staging CKD stage 4-5 (GFR < 30ml/min/1.73m2) and dialysis patients. 2. TCM syndrome differentiation conforms to the syndrome of epidemic toxin closing lung or yang deficiency and epidemic toxin invading lung. 3. The age is between 18 and 85; 4. The subjects agreed and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with serious diseases of important organs, such as moderate and severe liver dysfunction (transaminase is 3 times higher than normal), malignant tumor, severe anemia (HB is less than 60g/L), and cardiovascular and cerebrovascular stent implantation in recent 3 months; 2. Those who are taking immunosuppressants or other antiviral drugs and cannot stop using them; 3. Those who are allergic to the known components of the test drug or are severely allergic. 4. Pregnant or lactating women 5. Participated in other clinical trials 3 months before screening. 6. Other circumstances in which the researcher judges that the compliance is poor or that it is not suitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Time interval and proportion from random to clinical improvement (clinical symptoms include respiratory rate, skin oxygen, oxygenation index PaO2/FiO2, CT imaging changes, subject to the improvement time of the last index);Improvement time of chest CT and the proportion of patients;

Secondary

MeasureTime frame
The proportion of subjects whose disease progressed to critical condition during the observation period of 28 days after randomization.;All-cause mortality of the subjects in the observation period of 28 days after randomization;Time interval from random to discharge;The proportion of patients whose TCM syndrome score decreased by =30% during the observation period of 14 days after randomization;Inflammation index;Tcm syndrome curative effect score;

Countries

China

Contacts

Public ContactXudong Cai

Ningbo Hospital of Traditional Chinese Medicine

13777124877@163.com+86 137 7712 4877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026